Manager, Pharmacovigilance QA, Open to flexibility
Manager, Pharmacovigilance QA, Open to flexibility
(Please note, this position can also be based remotely from a GSK European LOC.)
A fantastic opportunity has arisen for an experienced individual to join as a PVQA Manager. The main Purpose of this role is to provide PV Quality Assurance within GSK R&D, by providing input into the development, management, and implementation of strategies and initiatives, policies and procedures to support the PV audit program across Pharma R&D, Biologicals and Consumer Healthcare.
The key Responsibilities include;
- Assist in the development, management, and implementation of strategies and initiatives, policies and procedures to support the PV audit program across Pharma R&D, Biologicals and Consumer Healthcare
- Primary internal customer base includes LOCs, Medical Governance QRM, GCSP, VCSP, QPPVs, GRA
- Pro-actively perform as a risk-management consultant, providing expert advice in relation to obtaining compliance, quality improvement, process and program initiatives, and risk assessment
- Responsible for training and providing performance feedback for less experienced staff
- Act as inspection coordinator for PV related regulatory authority inspections of GSK
- Generate and provide metrics, status and periodic reports and other information to identify trends and develop improvements across the business
- Liaise with Medical Governance Quality Risk Management Directors, Vaccines Quality Risk Managers, PV and safety managers
- Assist in developing, supporting and maintaining customer training programmes and help deliver training within area of expertise
- Develop PV training program to PVQA & CDQA advisors
- Interact with regulatory agencies in designated region(s) as appropriate or as needed
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.
If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
Closing date for applications: 19th April 2018
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.
Thank you for your interest in this opportunity.
- Bachelor's degree in related Life Science, Pharmacy, or related discipline.
- Equivalent experience will be considered
- Ability and desire for frequent domestic and international travel (approximately 25-40%)
- A broad scientific/pharmaceutical industry background with relevant experience in pharmaceutical research and drug safety
- Good Pharmacovigilance Practice Compliance, Good Clinical Practice Compliance and/or Quality Assurance
- Expert knowledge of global, regional and national PV regulatory requirements and regulations
- Detailed knowledge of the drug/clinical development processes and R&D Systems
- Detailed knowledge of pre and post marketing PV/MV activities associated with different areas of the business (e.g., clinical trials, manufacturing, regulatory affairs, commercial, toxicology)
- Ability to work independently and make decisions with minimal supervision
- Must have a high degree of organizational awareness and working towards resolution with complex problems
- Have demonstrated project management skills and management of complex cross-functional activities
- Have demonstrated ability for good verbal, written and presentation skills
GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery for strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.
You may apply for this position online by selecting the Apply now button.
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